Glycemic Control and the Brain in Children With Type 1 Diabetes

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The purpose of this study is to determine if improving diabetes control by better controlling blood sugars, will help improve or normalize brain function as compared to routine diabetes care. We will use either the patient's own insulin routine (injections or insulin pumps) or a closed-loop insulin pump (Medtronic 670G). This system uses a continuous glucose monitor (CGM) and an insulin pump to automatically give insulin and may improve control of blood sugars.

Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.

Active Comparator: Closed-Loop

Subjects will transition from their current treatment (insulin pump or injections) onto the Medtronic 670G insulin pump (intervention arm as a comparator) and will have close contact with the study team. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.

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Ages Eligible for Study:

14 Years to 17 Years (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Be at least 14 and not yet 18 years old

Must have been diagnosed with T1D prior to 5 years old but after 6 months

For those diagnosed prior to 1 year of age, a positive blood test for an antibody marker will be required

Have been born term or near term (≥34 weeks) and weighed more than≥ 2 kg (4.4lbs) at birth

Be in puberty

Exclusion Criteria:

History of intellectual disability, language or learning disability identified before diagnosis of diabetes, or enrollment in a self-contained special education program

ADD/ADHD and/or on stimulant medication

Any known genetic or medical problem that could impair brain development

Abnormalities of the brain/nervous system, visual or hearing problem

History of seizures not associated with fever before diabetes diagnosis

Previous inpatient psychiatric treatment

Unable to have a MRI of the head due to having metal: including metal ear tubes, full set of braces in mouth (retainer is acceptable), other appliances, or vascular clip

In accordance with the NIH data sharing policy, a de-identified database will be placed in the public domain after the completion of the study. This will be timed if possible with publication of the manuscripts that will result from these studies. In addition, formal requests for data will be accepted and reviewed by the DirecNet Steering Committee. If the request is approved, the Data Coordinating Centers will provide the data in a format mutually agreeable to the requesting party.